Regulatory Affairs and Quality Assurance Graduate Program at Temple University School of Pharmacy

Sterile Process Manufacturing Certificate (Pre-Master's)

Student Testimonial

"I have wanted to work with sterile products for the past few years, and the option for a Certificate in Sterile Process Manufacturing is partly why I selected Temple's RAQA graduate program. Coincidentally, a few months after starting this Certificate, I landed a job in Regulatory Affairs for a sterile durg product manufacturing site. I have learned so much on the job, but the classes on sterile products I have taken for this Certificate have been a big help in understanding sterile drugs and how they are developed and manufactured. It is quite an experience to learn someting in class and to be able to directly apply that understanding in the office in the following week. It truly made me appreciate those classes and feel more confident in choosing this Certificate."

Sterile products must be manufactured in a manner that eliminates or minimizes microbial contamination. Generally, sterile devices are manufactured in clean environments, while sterile drug products are manufactured using aseptic (or free from contamination) process methods where the drug substance, excipients, and vehicle (e.g., saline or water for injection) are combined and filled into a container (such as a syringe). Often times, the final dosage form cannot be sterilized at the end of the manufacturing process, since the drug substance would become degraded; sterility must be assured during the manufacturing process by using microbial controls, sterile filtration, and facility design, all of which must follow regulatory guidelines.

This four-course certificate explores the routes and types of sterile product administration, manufacturing and facility requirements for their design and production, as well as validation and compliance specifications. Attention is also focused on the technical and regulatory aspects of sterilization processes, including thermal, gaseous, radiation, filtration, and aseptic processing methods.

Students must complete two required courses:

Microbiological Concepts in Pharmaceutical Manufacturing (5512)

Production of Sterile Products (5492) OR Sterilization Processes (5493)

All materials must be received by the stipulated deadlines (January 15 for February issuance; May 15 for June issuance; and August 20 for September issuance). Sorry, but if you miss the deadline, you will have to wait until the next time certificates are issued. Certificates will be mailed to your home in late February, late June, or late September.

Note: Students may obtain only one certificate
before completing the MS program, except for Food RA and QA.